Z-1805-2016Class II
American Surgical Telfa 1" x 1" Ref Number: 80-12
American Surgical Company, LLC / initiated 2016-03-31 / Terminated / root cause: packaging
American Surgical Company began a recall of American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges on . FDA classified it as Class II and gives the reason as "Product packaging defective compromising sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1805-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- American Surgical Company, LLC
- Product
- American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Product code
- HBA Neurosurgical Paddie
- Reason for recall
- Product packaging defective compromising sterility
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]
- Quantity in commerce
- 10 boxes
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
- Product codes and lots
- Lot numbers: 2015/08 CI 2015/12 CU
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1721-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1722-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1723-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1724-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1725-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1726-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1727-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1728-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1729-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1730-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1731-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1732-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1733-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1734-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1735-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1736-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1737-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1738-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1739-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1740-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1741-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1742-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1743-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1744-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1745-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1746-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1747-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1748-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1749-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1750-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1751-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1752-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1753-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1754-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1755-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1756-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1757-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1758-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1759-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1760-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1761-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1762-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1763-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1764-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1765-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1766-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1767-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1768-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1769-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1770-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1771-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1772-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1773-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1774-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1775-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1776-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1777-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1778-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1779-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1780-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1781-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1782-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1783-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1784-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1785-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1786-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1787-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1788-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1789-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1790-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1791-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1792-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1793-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1794-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1795-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1796-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1797-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1798-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1799-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1800-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1801-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1802-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1803-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1804-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1805-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1806-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1807-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1808-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1809-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1810-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1811-2016 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.